BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-LOC 180

    MDR report key: 15439350 · Received September 16, 2022

    Report

    Report Number
    1219930-2022-03667
    Event Type
    Injury
    Date Received
    September 16, 2022
    Date of Event
    September 1, 2022
    Report Date
    September 16, 2022
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    UDI-DI
    10884521068278
    PMA / PMN Number
    K111442
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT PMEDICAL PRODUCT/S: VLOCA008L VLOCA008L V-LOC* 180 0 ABS RELOAD 20CM LOT/SERIAL #:N1M0731Y; VLOCA008L VLOCA008L V-LOC* 180 0 ABS RELOAD 20CM STAP LOT/SERIAL #:(B)(4); 173016 173016 ENDO STITCH INSTRUMENT STAP LOT/SERIAL #:(B)(4); 173016 173016 ENDO STITCH INSTRUMENT STAP LOT/SERIAL #:(B)(4). MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHILE CLOSING THE VAGINAL CUFF, THE RELOAD AND HANDLE WERE CYCLED TO ENSURE IT WAS PROPERLY LOADED PRIOR TO USE. DURING USE, THE SUTURE DISENGAGED FROM THE INSTRUMENT AND FELL INTO THE PATIENT'S PELVIC CAVITY. THE SURGEON RETRIEVED THE SUTURE WITH THE NEEDLE STILL ATTACHED USING A GRASPER. THE TECHNICIAN THEN TRIED UNLOADING THE DEVICE, BUT THE INSTRUMENT WAS JAMMED AND WAS UNABLE TO UNLOAD. A SECOND HANDLE AND RELOAD WERE OPENED AND CYCLED NUMEROUS TIMES TO CONFIRM IT WAS PROPERLY LOADED. DURING USE THE SECOND SUTURE'S NEEDLE POPPED OFF OF THE SUTURE AND WAS STUCK IN THE PATIENT'S TISSUE. THE SURGEON RETRIEVED THE NEEDLE WITH A GRASPER. A THIRD RELOAD WAS LOADED AND CYCLED A FEW TIMES BEFORE USE. DURING USE THE NEEDLE CRACKED AND A PIECE FELL INTO THE PATIENT'S PELVIC CAVITY. THE SURGEON WAS ABLE TO LOCATE AND RETRIEVE THE NEEDLE PIECE. IT WAS NOTED THAT ONE NEEDLE THAT WAS RETRIEVED FROM THE CAVITY GOT STUCK IN THE TROCAR. A FOURTH RELOAD WAS USED TO COMPLETE THE CLOSURE OF THE CUFF. THIS LED TO 30 MINUTES OR MORE EXTENDED SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467438 V-LOC 180 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN VLOCA008L 10884521068278

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention